Orthotic Device

ABSTRACT

An orthotic device having a plantar support surface to support the plantar (sole) of the forefoot portion of the foot. The plantar support surface has two walls on opposing sides. One wall supports the outer portion of the big toe and the other wall supports the outer portion of the small toe. These walls act immobilize the forefoot region of the foot and more importantly immobilize the big toe effectively eliminating or reducing pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus.

This application claims priority to U.S. provisional application Ser. No. 61/634,535 filed Mar. 2, 2012, which is incorporated herein by reference in its entirety.

FIELD OF INVENTION

The present invention relates generally to the field of orthotic devices. More particularly, the subject matter is directed to an orthotic device to eliminate or reduce pain to those suffering from a foot disorder in the first metatarsal such as hallux limitus or hallux rigidus.

BACKGROUND

Disorders of the big toe joint are common. Such disorders include hallux limitus and hallux rigidus. These disorders are known to be extremely painful and can even be disabling since we use our big toe whenever we walk, climb stairs or just stand. In some cases these disorders require surgery to eliminate or reduce the pain. In other cases, non-surgical treatment can be used to eliminate or reduce the pain.

A number of non-surgical methods have been used to treat these conditions including use of pharmaceuticals (applied topically or by injection) or mechanical devices.

U.S. Pat. No. 7,849,610 discloses a slab configured to be placed underneath a big toe, forward of and not extending under a head of a first metatarsal, wherein the slab has a predetermined height so as to deflect a proximal phalanx upwardly relative to the first metatarsal. This can be uncomfortable as such a device places the toe in an unnatural position. This may also severely interfere with the flexing that is required for a normal walking gate leading to a limp which can cause other injuries to form.

U.S. Pat. No. 6,454,733 discloses a foot strap that wraps around a toe of the foot and then wraps around the main body of the foot and heel in order to maintain the wrapped toe in a desired orientation. Another similar method used to immobilize a toe includes what is known as spica taping whereby tape is laid across the toe and then taped to the bottom of the foot to prevent or limit upward flexing of the toe. While these methods provide for ways to partially immobilize the big toe in order to eliminate or reduce pain in the foot due to conditions associated with functional limitation of the hallux such as hallux limitus or hallux rigidus they have disadvantages. One disadvantage is that they require the individual to apply the immobilizing device by wrapping with the proper tension which can be difficult. If wrapped too tight it can lead to decreased blood circulation in the foot and if wrapped too loosely it may not be effective. Another disadvantage is that the wrap may loosen over time as it is worn and thus becoming less effective and requiring the user to rewrap during the day.

Another known method includes modifications to shoes to enlarge the toe box to reduce pressure on the toe.

There remains a need for a simple yet effective orthotic device to eliminate or reduce pain in the foot due to conditions associated with functional limitation of the hallux such as hallux limitus or hallux rigidus that does not require the user to constantly immobilize their toe in some type of wrapping or use a device that places the toe in an unnatural position causing further discomfort.

SUMMARY OF THE INVENTION

Provided is an orthotic device to eliminate or reduce pain in the foot, specifically the first metatarsal, due to conditions associated with functional limitation of the hallux such as hallux limitus or hallux rigidus. The device may also be used with other foot conditions including posttraumatic arthritis, osteoarthritis, turf toe hyperextension injuries, occupational overuse injuries, gouty arthritis, and bunion (hallux valgus). The orthotic device of the present invention immobilizes the big toe thereby eliminating or reducing pain in the foot due to conditions associated with functional limitation of the hallux such as hallux limitus or hallux rigidus. The immobilization can be either full or partial immobilization of the big toe.

The orthotic device has a plantar support surface to support the plantar (sole) of the forefoot portion of the foot. The plantar support surface has two walls on opposing sides. One wall supports the outer portion of the big toe and the other wall supports the outer portion of the small toe. These walls act to immobilize the forefoot region of the foot and more importantly immobilize the big toe effectively eliminating or reducing pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus.

In another embodiment, the orthotic device has a plantar support surface which support the entire plantar (sole) of the foot. The plantar support surface has two walls on opposing sides towards the forefoot portion of the orthotic device. One wall supports the outer portion of the big toe and the other wall supports the outer portion of the small toe. These walls act to immobilize the forefoot region of the foot and more importantly immobilize the big toe effectively eliminating or reducing pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus. This design has a plantar support surface that runs along the entire sole of the foot thereby providing support to the entire sole. The two opposing walls are preferably only in the forefoot region but can extend further back along the foot into the midfoot and hindfoot regions. Such opposing wail configuration (i.e. where the opposing wails extend further back along the foot into the midfoot and hindfoot regions) can apply to this embodiment or any other embodiment of the present invention.

In another embodiment, the invention comprises a shoe having an orthotic device integrated into the insole. The orthotic device has a plantar support surface which supports the plantar (sole) of the foot. The plantar support surface can support either the entire sole of the foot or just the forefoot region. The plantar support surface has two walls on opposing sides towards the forefoot portion of the orthotic device. One wall supports the outer portion of the big toe and the other wall supports the outer portion of the small toe. These walls act to immobilize the forefoot region of the foot and more importantly immobilize the big toe effectively eliminating or reducing pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus.

In another embodiment, an orthotic device as disclosed herein has a mechanism for holding the orthotic device in place. This mechanism can be an elastic sleeve that slides over the orthotic device, an adjustable strap that is either connected to the device or wraps around it to hold it in place. The mechanism can also be a sock whereby the orthotic device is worn under the sock and the sock is placed over the device and acts in part to hold of the orthotic device in place. The orthotic device can also be worn over a sock and a second sock, sleeve or strap is used to secure the orthotic device in place.

In another embodiment, an orthotic device as disclosed herein wherein the forward edge is rounded upward to form a toe piece mechanism to aid in holding the orthotic device in proper place.

In a preferred embodiment, a rigid support is incorporated into or onto the device below the foot and running from behind the first metatarsal toward the front of the big toe. The rigid support can vary in dimension but is preferably about 0.25 to 1.5 inches in width, 1.0 to 6.0 inches in length and 0.01 to 0.5 inches in height. It is further preferable that the height of the rigid support is no more than 0.25 inches.

In a more preferred embodiment, the rigid support has a soft cushion covering for the forefoot to rest and more preferably the big toe. The soft cushion covering can vary in dimension but is preferably about 0.25 to 1.5 inches in width, 1.0 to 6.0 inches in length and 0.01 to 0.5 inches in height. It is further preferable that the height of the soft cushion covering is no more than 0.25 inches.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an embodiment of a device according to the present invention.

FIG. 2 illustrates a top view of an embodiment of a device according to the present invention.

FIG. 3 illustrates a bottom view of an embodiment of a device according to the present invention.

FIG. 4 illustrates a top view of an embodiment of a device according to the present invention.

FIG. 5 illustrates a front view of an embodiment of a device according to the present invention.

FIG. 6 illustrates a side view of an embodiment of a device according to the present invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENT

Various terms relating to aspects of the description are used throughout the specification and claims. Such terms are to be given their ordinary meaning in the art unless otherwise indicated. Other specifically defined terms are to be construed in a manner consistent with the definitions provided herein.

All references cited herein are incorporated by reference in their entirety and for all purposes.

As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise.

The term “forefoot” as used herein refers to the region of the foot containing the five phalanges (toes) and the five metatarsals bones and as shown in FIG. 6.

The term “midfoot” as used herein refers to the region of the foot that forms the arch of the foot and includes the three cuneiform bones, the cuboid bone, and the navicular bone and as shown in FIG. 6.

The term “hindfoot” as used herein refers to the heel region of the foot and includes the calcaneus bone (heel bone) and as shown in FIG. 6.

The term “plantar” as used herein refers to the bottom surface of the foot or the sole of the foot.

“Immobilize” and word variants thereof as used herein, is intended that the mobility of the toe is reduced but not necessarily fully reduced. The toe can be completely immobilized or partially immobilized.

In a preferred embodiment shown in FIGS. 1 to 6, the present invention provides an orthotic device 10 having a plantar support surface 20 to support the plantar (sole) of the forefoot portion 2 of the foot. Preferably the front edge 28 of plantar support surface 20 begins in the forefoot region of the foot 2 and the back edge 30 of the plantar support surface ends in the forefoot region 2 of the foot or the midfoot region 4 of the foot. The plantar support surface 20 has two walls on opposing sides 22 and 24 that extend vertically upward along the outer side of the foot 8 and inner side of the foot 9. In this embodiment and other embodiments discussed herein, extend vertically upward does not require that the lateral walls 22 and 24 (or respective features in other embodiments/figures) to extend straight up from the plantar support surface 20 but rather that they curve upward from the side ends 20 a and 20 b of the plantar support surface 20 to form a raised side wall sufficient to provide support on the outer side/edges of foot 8 and 9. The wall 22 on the inner side 9 of the foot acts to support the outer surface 25 of the big toe/first metatarsal. The other wall 24 on the outer side 8 of the foot acts to support the outer surface 27 of the small toe/fifth metatarsal. While the objective is to immobilize the big toe to eliminate or reduce pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus, the two outer walls 22 and 24 act together to immobilize the forefoot region of the foot effectively immobilizing the big toe. In the various embodiments herein, the two side walls 22 and 24 are preferably formed by a curvature stemming from the two side ends 20 a and 20 b of the plantar support surface 20. This curvature will make the orthotic device more comfortable. For additional comfort, the plantar support surface 20 may also have padding along at least a portion of the top surface in contact with the plantar part of the foot.

In other embodiments, the outer side wall 24 is optional as it is the big toe/first metatarsal that is intended to be immobilized. Other means may be used to help secure the device in place therefore making the outer side wall 24 optional in certain embodiments.

In another embodiment, the orthotic device has a plantar support surface 20 which extends along and supports the entire plantar (sole) of the foot from the hindfoot 6 to the forefoot 2 (extended plantar support surface not depicted in the figures). Accordingly, in this embodiment the plantar support surface 20 extends from the forefoot 2 to the hindfoot 6. Similar to the device described above and depicted in FIGS. 1 to 6 the plantar support surface 20 has two walls on opposing sides 22 and 24 that extend vertically upward along the outer side of the foot 8 and inner side of the foot 9. Preferably walls 22 and 24 extend only in the forefoot region 2 of the foot but they can extend to the midfoot region 4 or hindfoot region 6 in certain embodiments. Extending the walls further back may be useful in certain embodiments to assist in holding the device securely in place. The side wall 22 on the inner side 9 of the foot acts to support the outer surface 25 of the big toe. The other wall 24 on the outer side 8 of the foot acts to support the outer surface 27 of the small toe. While the objective is to immobilize the big toe to eliminate or reduce pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus, the two outer walls 22 and 24 act together in this embodiment to immobilize the forefoot region of the foot 2 effectively immobilizing the big toe.

In another embodiment, an orthotic device as disclosed herein is incorporated into a shoe.

In another embodiment, a securing mechanism is provided with the device to aid in holding the orthotic device in place. Such securing mechanism is preferably a flexible sleeve made out of fabric that slides over the orthotic device and the foot to hold the orthotic device in place. Other securing mechanisms can be used to firmly secure the orthotic device to the foot including a strap that wraps around the orthotic device and the foot, or an adjustable strap that is connected to the orthotic device and adjusted to firmly secure the orthotic device to the foot. In a further embodiment, the device will have a means to fasten the securing mechanism to the device 35 such as a Velcro piece, button or other fastening means to which a strap, sleeve, sock or other securing means may be attached. While the means to fasten the securing mechanism to the device is depicted in the figures as being located on the bottom of the plantar support surface, the securing mechanism can be fastened to the device at any part of the device. Additionally, multiple securing means and fastening means may be used in the device. Such multiple means being of the same or different type.

In another embodiment, an orthotic device as disclosed herein wherein the forward edge 28 is rounded upward to form a front wall which acts as a toe piece mechanism to aid in holding the orthotic device in proper place.

In another embodiment, an orthotic device as described herein is custom molded to an individual's foot to provide greater comfort and/or additional orthotic treatment.

In a preferred embodiment, a rigid support 40 is incorporated into or onto the device below the foot and running from behind the first metatarsal toward the front of the big toe. Preferably the rigid support is only under the first metatarsal/big toe as it is intended to provide additional support to immobilize the first metatarsal/big toe effectively eliminating or reducing pain associated with movement of the big toe due to conditions such as hallux limitus or hallux rigidus. The rigid support 40 can vary in dimension but is preferably about 0.25 to 1.5 inches in width, 1.0 to 6.0 inches in length and 0.01 to 0.5 inches in height. It is preferable that the height of the rigid support 40 is no more than 0.25 inches. The rigid support may be made out of any solid material that provides sufficient rigidity and support. In a preferred embodiment the rigid support is a graphite tongue.

In a more preferred embodiment, the rigid support 40 has a soft cushion covering 42 for the forefoot to rest and more preferably the big toe. The soft cushion covering 42 can vary in dimension but is preferably about 0.25 to 1.5 inches in width, 1.0 to 6.0 inches in length and 0.01 to 0.5 inches in height. It is further preferable that the height of the soft cushion covering 42 is no more than 0.25 inches. The soft cushion covering preferably is only below the first metatarsal/big toe but it may be under the entire forefoot or other portions of the foot as well. The soft cushion 42 can be made up of any soft material but preferably is adhesive silicone gel applied to hypafix tape in order to fasten it to the rigid support 40 or the device 10.

The body of the device 10 is made of a solid material such as those typically used to make orthotics. Preferably, the device is made of a polyethylene thermoplastic. 

What is claimed:
 1. A foot orthotic device comprising: a plantar support surface to support the forefoot portion of the foot in said device; said plantar support surface having a first lateral side along the big toe and a second lateral side along the small toe; a first wall on the first lateral side and second wall on the second lateral side; said first wall being of sufficient height to support the outer edge of the big toe; and said second wall being of sufficient height to support the outer edge of the small toe.
 2. A foot orthotic device according to claim 1, wherein the plantar support surface does not extend beyond the forefoot.
 3. A foot orthotic device according to claim 1, wherein the plantar support surface extends from the forefoot to the midfoot.
 4. A foot orthotic device according to claim 1, wherein the plantar support surface extends from the forefoot to the hindfoot.
 5. A foot orthotic device according to claim 1, further comprising a means to secure said device to the foot.
 6. A foot orthotic device according to claim 5, wherein said mean to secure comprises a flexible sleeve.
 7. A foot orthotic device according to claim 5, wherein said mean to secure comprises a strap.
 8. A foot orthotic device according to claim 5, wherein said mean to secure comprises a strap that is connected to the first wall and second wall.
 9. A foot orthotic device according to claim 5, wherein said strap has elastic properties.
 10. A foot orthotic device according to claim 5, wherein said strap is adjustable.
 11. A foot orthotic device according to claim 1, wherein a rigid support is incorporated either into or onto an upper surface of the plantar support surface.
 12. A foot orthotic device according to claim 11, wherein the rigid support is located under the where the first metatarsal/big toe would rest on the device.
 13. A foot orthotic device according to claim 11, wherein a soft cushion covering covers said rigid support. 